A Study of Amifostine for Prevention of Facial Numbness in Radiosurgery Treatment of Trigeminal Neuralgia

Trigeminal Neuralgia Clinical Trial

Official title:

A Randomized, Placebo-controlled Trial of Amifostine for Prevention of Facial Numbness in Patients Receiving Stereotactic Radiosurgery for Trigeminal Neuralgia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01364259
• Other study ID #: SU-05252011-7806
• Status: Recruiting
• Phase: Phase 3
• First received: May 26, 2011
• Last updated: June 1, 2011
• Start date: September 2008
• Est. completion date: January 2015

Study information

• Verified date: May 2011
• Source: Stanford University
• Contact: Lisa Jacobs
• Phone: (650) 723-8843
• Email: ljacobs[@]stanford.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Trigeminal neuralgia or tic douloureux is severe, often debilitating, facial pain that significantly impairs the patient's quality of life and health. Stereotactic radiosurgery has been shown to provide pain relief in majority of patients treated. However, a common side effect of radiosurgery is facial numbness. Our goal is to maximize pain control while minimizing side effects. To this end, the purpose of this study is to evaluate whether adding a drug, amifostine, at the time of radiosurgery will protect patients from facial numbness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: January 2015
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All patients age 18 years and older with typical trigeminal neuralgia, as determined by diagnostic criteria set by the International Headache Society, who are:

• Intolerant of or refractory to medical management; AND

• Not candidates for or refusing a surgical micro-vascular decompression.

Exclusion Criteria:

• Patients who present with pre-existing BNI grade III or IV facial numbness.

• Patients who have previously been treated with MVD.

• Patients who have previously had an ablative treatment, including prior SRS.

• Pediatric patients (age <18), pregnant women, and patients who are unable to give informed consent will be excluded.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Drug:
• Amifostine
Amifostine and CyberKnife stereotactic radiosurgery

Procedure:
• CyberKnife stereotactic radiosurgery
CyberKnife stereotactic radiosurgery

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial numbness following radiosurgery	Percent of patients with facial numbness following radiosurgery will be determined.	1 year	No
Secondary	Pain relief following radiosurgery	Pain score following radiosurgery will be measured. Latency to pain relief will be assessed.	6 months	No